Cleared Traditional

K952113 - TBN-TIPPED OPTICAL FIBER

K952113 is an FDA 510(k) clearance for TBN-TIPPED OPTICAL FIBER, manufactured by Myriad Lase, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K952113 · Myriad Lase, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
27d
Days
Class 2
Risk

K952113 is an FDA 510(k) clearance for the TBN-TIPPED OPTICAL FIBER. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Myriad Lase, Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 1, 1995 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K952113

510(k) Number K952113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1995
Decision Date June 01, 1995
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2835
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K952113.
MEGABEAM ASPIRATING ENDOCULAR PROBE
K952340 · Ceram Optec, Inc. · Jun 1995
MODEL 550-DC CROSSFIRE(TM)
K945564 · Eclipse, Inc. · Jun 1995
SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR
K951204 · Sharplan Lasers, Inc. · Jun 1995
MEDICAL MIXTURE-LASER GAS MIXTURES
K952162 · Standard Welders Supply Co. · Jun 1995
LASER GAS MIXTURE
K952301 · Airgas Management, Inc. · Jun 1995
ACCU-BEAM FIBER OPTIC HANDPIECE
K952006 · Tti Medical · May 1995
K952113 · TBN-TIPPED OPTICAL FIBER
Download PDF Myriad Lase, Inc.